- Significant Improvements Reported Over Placebo Across All Study Endpoints; Effects of Therapy Observed to Build Over Time -
EXTON, Pa., Oct. 22 /PRNewswire-FirstCall/ -- Isolagen(TM), Inc.
(Amex: ILE) presented today an analysis of results from the completed pivotal
Phase III studies (Studies IT-R-005 and IT-R-006) of the Isolagen Therapy(TM)
for the treatment of nasolabial folds, or wrinkles. Both studies, conducted
under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment
(SPA), reported statistically significant results meeting all primary
endpoints. The analysis was presented today in a company webcast. Please
visit www.isolagen.com for the complete audio and slide presentation.
'The full analysis of data from these pivotal safety and efficacy studies
is very exciting and further supports the potential of Isolagen Therapy as an
innovative treatment for wrinkles. In addition to improving the appearance of
wrinkles, the effects of Isolagen Therapy in the studies were observed to
build over time, which may allow for gradual rejuvenation of the skin,' said
Stacy R. Smith, M.D., study investigator and Assistant Clinical Professor,
Division of Dermatology, University of California San Diego. 'There is a
growing demand for minimally invasive procedures that rejuvenate the skin.'
The Isolagen Process(TM) is a proprietary cellular processing system that
creates a natural, living cell therapy. By multiplying a person's own
collagen-producing cells, or fibroblasts, into tens of millions of new cells,
a personalized treatment is created that is then returned to the person's skin.
This first-of-its-kind aesthetic treatment, known as Isolagen Therapy, is
designed to improve skin damage caused by the normal effects of aging, sun
damage, acne and burns.
'We are very pleased with the analysis of our Phase III pivotal studies,
which highlights the potential of Isolagen Therapy to provide a unique
treatment paradigm in the field of medical aesthetics,' said Declan Daly,
President and Chief Executive Officer of Isolagen.
